Nobel Biocare recalls implant retrieval kits due to potential contamination of sterilized medical devices in the packaging. Affected kits may not remain sterile during shelf life, posing infection risks. Consumers should check serial numbers and contact the company for details.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Nobel Biocare is recalling implant retrieval kits because the packaging sealing process could lead to contaminated sterilized medical devices. This means the devices might not stay sterile for their shelf life, increasing infection risk during medical procedures.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices inside could become contaminated over time. This contamination could lead to infections during medical procedures if the devices are not properly sterile.
Medical professionals who use these kits for procedures are most at risk. Patients undergoing surgery with these kits could face infection if the devices are not sterile.
Check the serial numbers listed in the recall notice: 857717, 857597, 857656, 818712, 818747, 818647, 857578, 857610, 857615, 857653, 857677, 857694, 857708, 857711, 857729, 857732, 818682, 818811. These kits were sold between August 2018 and January 2019.
Look for the serial numbers listed in the recall notice (e.g., 857717, 857597) on the kit packaging or label.
Reach out to Nobel Biocare USA LLC for further instructions on how to handle the recalled kits.
The packaging sealing process at the supplier may have failed, meaning the sterilized devices could become contaminated over time, increasing infection risk during medical procedures.
Check the serial numbers listed in the recall notice and contact Nobel Biocare USA LLC for further instructions.
Yes, if the devices are not sterile, they could cause infections during medical procedures, particularly for patients undergoing surgery.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-1323-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-1323-2020 from Nobel Biocare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
